Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study

Recruiting

• Conditions: Heart Failure; Neoplasm, Breast; Ventricular Dysfunction; Cardiotoxicity
• Interventions: Diagnostic Test: Echocardiography

• Registration Number: NCT05851053
• Lead Sponsor: University Medical Center Groningen

Brief Summary

Rationale: In addition to surgery, effective breast cancer (BC) treatment typically requires chemotherapy, radiotherapy, or both. However, it is still unclear whether patients with BC are at increased risk of long-term cardiac dysfunction due to the adverse effects of these therapies. In a cross-sectional study in primary care, a comparison on cardiac dysfunction between 350 BC survivors and 350 age- and general practitioner (GP)- matched controls without cancer was made. In that study, BC survivors were at increased risk of mild systolic cardiac dysfunction (left ventricle ejection fraction (LVEF)\< 54%). By contrast, there was no significant difference in an LVEF \< 50% or in diastolic dysfunction. To date it remains uncertain whether the mild or subclinical dysfunction we observed predicts further cardiac deterioration. Consequently, the translation of these results into guidelines for the daily practice of the GP is unclear.

Objective: The aim of the here proposed study is to clarify whether cardiac function in survivors of BC should be monitored by GPs, by assessing whether an unselected population of long-term BC survivors is at increased risk of developing cardiac dysfunction, whether in this group at-risk subgroups exists, and what factors are associated with the highest risk.

Study design: A new assessment of cardiac function among women included in the BLOC-I study. This produces a longitudinal matched cohort design consisting of two cohorts in primary care.

Study population: Survivors of BC, diagnosed ≥11 years ago who received chemotherapy and/or radiotherapy, and a matched reference population with no history of cancer. All participants participated in the Breast cancer Long-term Outcome of Cardiac function (BLOC-I) study.

Main study parameters/endpoints: Left ventricular systolic dysfunction. Systolic cardiac dysfunction is defined as a LVEF \<54/50/45%.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 455

Inclusion Criteria

• Patients who previously took part in de BLOC-I study will be included. These criteria were:
• females diagnosed with stage I-III BC at least five years ago or local or locoregional recurrence of BC at least five years ago
• treatment with chemotherapy and/or radiotherapy.

Exclusion Criteria

• Patients unfit to travel to the hospital due to severe mental or physical illness, based on assessment by their GP.

Exclusion criteria for the BC survivors in the BLOC-I study were:

• metastatic disease at the time of BC diagnosis;
• BC treatment after 80 years of age;
• history of treatment for other types of cancer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer survivors	Echocardiography	Survivors of BC, diagnosed ≥11 years ago, who received chemotherapy and/or radiotherapy
Reference population	Echocardiography	Age and GP matched reference population without a history of cancer

Primary Outcome Measures

Name	Time	Method
Left ventricular systolic dysfunction	through study completion (from Ocotober 2022 - December 2024)	Prevalance of systolic cardiac dysfunction defined as a LVEF \<54%

Secondary Outcome Measures

Name	Time	Method
Clinically used LVEF cut-off points <45% and <50%	through study completion (from Ocotober 2022 - December 2024)	Prevalance of systolic cardiac dysfunction defined as a LVEF \<45% and \<50%
Cardiovascular diseases	through study completion (from Ocotober 2022 - December 2024)	Prevalence of cardiovascular diseases obtained from electronic patient records
Course of cardiac function	through study completion (from Ocotober 2022 - December 2024)	Rate of change of systolic and diastolic cardiac function by change in LVEF
Symptoms of hearth failure	through study completion (from Ocotober 2022 - December 2024)	Clinical symptoms of heart failure measured using a self-constructed questionnaire

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands